Devices

Device Recall dissector PlasmaKnife (DPK)

Model / Serial
Lot Numbers: 0805064, 0805102, 0805103, 0806030, 0806039, 0806187, and 0807021
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution --- including USA and countries of Canada, UK, Italy, Spain, Norway, Australia, and Taiwan.
Product Description
Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) || Catalog No: 7035-3005 || A single use only bipolar electrosurgical instrument with the ability to cut and coagulate soft tissue in head and neck surgery within an ambient air environment.
Manufacturer
Gyrus ACMI Corporation
1 Event
- Recall of Device Recall dissector PlasmaKnife (DPK)

Manufacturer

Gyrus ACMI Corporation

Manufacturer Address
Gyrus ACMI Corporation, 136 Turnpike Road, Southborough MA 01772
Manufacturer Parent Company (2017)
Olympus Corporation
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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